A Safety & Efficacy Study of Treatment With AP1189 in Rheumatoid Arthritis Patients naïve to DMARD Treatment (EXPAND)

A Double-blind, Multi-center, Randomized, Placebo-controlled Study of the Safety and Efficacy of 12 Weeks Extended Treatment With AP1189 in Early Rheumatoid Arthritis (RA) Patients naïve to DMARD Treatment

The study is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of 12 weeks daily treatment with 100 mg AP1189 in RA patients who are to start up-titration with methotrexate (MTX).

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: 100 mg AP1189; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 127
• Phase: Phase 2

Contacts and Locations

Study Locations

• Moldova, Republic of
  • Chișinău, Moldova, Republic of
    • Timofei Mosneaga Republican Clinical Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Main Inclusion Criteria:

• Confirmed diagnosis of RA according to the 2010 ACR/EULAR RA classification criteria and are ACR class I-III
• ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts).
• Candidate for MTX treatment
• Is about to begin treatment with MTX

• Must meet at least one of the following parameters at Screening:

  1. positive result for anti-CCP or RF
  2. Serum CRP ≥ 6 mg/L
• Highly active RA (CDAI > 22) at screening and baseline
• Negative QuantiFERON-in-Tube test (QFG-IT)
• Females of child-bearing potential must use of highly effective birth control method

Main Exclusion Criteria:

• Major surgery (including joint operation) within 8 weeks prior to screening or planned surgery within 1 month following randomization
• Rheumatic autoimmune disease other than RA, including systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis, or significant systemic involvement secondary to RA. Sjögren's syndrome with RA is allowable
• Prior history of or current inflammatory joint disease other than RA
• Subjects with fibromyalgia
• Use of hydroxychloroquine within 4 weeks prior the Screening Visit
• Initiation of, or change in existing NSAID treatment within 2 weeks prior to the baseline visit
• Corticosteroids except inhaled or nasal formulations for seasonal allergy or asthma are prohibited within 2 weeks prior to screening
• Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease
• Have prior renal transplant, current renal dialysis, or severe renal insufficiency
• Uncontrolled disease states, such as asthma, psoriasis, or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids
• Evidence of active malignant disease (except basal cell carcinoma of the skin that has been excised and cured)
• Neuropathies or other painful conditions that might interfere with pain evaluation
• Body weight of >150 kg
• HBsAg positive and/or Anti-HBc with sign of current infection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 100 mg AP1189; Treatment period of 12 weeks given as 1 tablet daily	Drug: 100 mg AP1189; AP1189 tablets for oral use; Other Names: AP1189 tablets for oral use
Placebo Comparator: Placebo; Treatment period of 12 weeks given as 1 tablet daily	Drug: Placebo; Matching placebo for oral use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of reported AEs	Evaluation of the safety and tolerability of AP1189 on the number and severity of reported Adverse Events, compared with placebo	12 weeks
Change in ACR20	The change in American College of Rheumatology 20% (ACR20) compared to baseline	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ACR50	The change in American College of Rheumatology 50% (ACR50) compared to baseline	12 weeks
Change in ACR70	The change in American College of Rheumatology 70% (ACR70) compared to baseline	12 weeks
Change in (CDAI)	The change Clinical Disease Activity Index (CDAI) compared to baseline	12 weeks
Change in DAS-28	The change in DAS-28, based on a CRP value, compare to baseline	12 weeks

Collaborators and Investigators

• Sponsor: SynAct Pharma Aps
• Collaborators: NBCD A/S

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2022
• Primary Completion (Actual): July 20, 2023
• Study Completion (Actual): July 20, 2023

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 26, 2022

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 3, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: SynAct-CS007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No